FUTILE ATROCITIES

THE WORLD OF ANIMAL EXPERIMENTATION has traditionally been extremely
secretive. That secrecy helps disguise both the destructive and
violent nature of vivisection and also the falsity of claims for
benefits from such brutality. It's deliberate manipulation of public
opinion to protect a self-serving, deluded and barbaric practice.

The Diaries of Despair documents published here by Uncaged Campaigns
represent a truly historic moment in one of the most controversial
and significant public debates in modern times. By overcoming a
legal attack designed to suppress the Diaries of Despair, Uncaged
Campaigns have achieved an extraordinary victory for democracy and
freedom of information. It is a blow for due process over brutal
tyranny. This time, might is not right.

Damning evidence

The major haul of documents was leaked
from Cambridge-based Imutran Ltd to Uncaged Campaigns in the spring
of 2000. The cache of information included:

39 'study reports' contained on a CD-ROM, most of which described
how, in experiments performed at Huntingdon Life Sciences (HLS),
Imutran researchers transplanted organs from genetically-altered
piglets into hundreds of higher primates: cynomolgus monkeys (a
kind of macaque) and wild-caught baboons. The study reports included
harrowing observations - 'clinical signs' - recorded twice daily
as the previously healthy primates sickened and died after the
experimental transplant operations. It was this disturbing evidence
that inspired the title "Diaries of Despair".

Internal reviews of the results of the experiments, giving further
insight into the horrific impact on the animals.

Confidential progress reports demonstrating the lack of success
in the experiments, contrary to the PR image created by Imutran
and their parent company Novartis.

Communications with the regulatory body - the Home Office -
revealing the indulgent and biased attitude of the Government
towards Imutran and HLS.

Faxes and letters with wildlife brokers concerning attempts
to import primates from half way across the globe to meet a grisly
fate at HLS.

Investigations into failures during the research, including
deaths of primates, breaches of laws and regulations, and failures
to meet Good Laboratory Practice standards at HLS.

In October 2002, Uncaged Campaigns received a
second leak of documents exposing Imutran's vivisection activities,
this time from the Home Office. These papers provide detailed and
highly unusual information about how companies and institutions
actually go about obtaining permission to experiment on animals.
The evidence contained in this second leak intensifies the concerns
raised in Diaries of Despair regarding the Government's rubber-stamp
approach to approving vivisection licences. Furthermore, these documents
reveal that Imutran submitted false information to the Government
in its applications for licenses to perform its experiments, a potentially
criminal breach of the Animals (Scientific Procedures) Act 1986.

The public never gets to see the manipulative and ruthless behaviour
of big corporations and feeble Governments. The Diaries of Despair
documents provides a truly unique opportunity to bring powerful
wrongdoers to account.

The Diaries of Despair report

In the months following the Imutran leak, Uncaged Campaigns director
Dan Lyons analysed the confidential documents and compared them
closely with the rules and regulations enshrined in UK law, ministerial
statements, as well as scientific reports and other statements issued
by Imutran. It soon became clear that the secret evidence demonstrated
that the rules that are supposed to govern animal experiments are,
in fact, a sham. The Government directly colludes with the vivisection
industry to help them evade the letter and spirit of the law. Ministers
even conceal wrongdoing and animal suffering in statements to Parliament.
Behind the smokescreen of confidentiality exists a culture of contempt
for the rule of law and for the welfare of animals. This is a tragic
scandal of historic proportions.

Originally published on 21 September 2000, the Diaries
of Despair report organises and explains the significance of
the Imutran documents. It reveals the awful cruelty inflicted on
these higher primates - the cousins of human beings. The gaps and
exaggerations in Imutran's carefully-filtered spin are exposed.
Ultimately, the appalling failure of Government in its most fundamental
duty - to enforce the law - is unmasked.

Dead on arrival

Thousands of pigs and several hundred higher primates were sacrificed
in Imutran's ill-fated xenotransplantation research programme. The
leaked documents focus on the ordeal endured by the primates - monkeys
and baboons - who were the experimental recipients of Imutran's
GM pig organs.

At least fifty baboons started life free, roaming the savannah
of East Africa. But they were wrenched from their tightknit clan
to suffer lonely and violent deaths thousands of miles away in a
bleak, windowless laboratory at HLS in Cambridgeshire.

They were captured on behalf of wildlife dealer Mann & Miller
Ltd, and held in a metal wire compound. Inspectors who visited the
site have been 'disgusted' by the conditions there, as the primates
scream and smash their heads on cage walls, driven mad by the isolation
and confinement. This leaked fax (see report page
31) reveals that some baboons didn't even make it to Britain:

"He says that he lost 4 animals this week. He
explained that the metal roof of the holding cage was struck by
lightning in a thunder-storm and 4 animals died as a result of the
strike..."

Another secret document (see report page
32) proves that the Home Office had been happy to approve these
lethal cages solely on the basis of submissions from Imutran, a
fact hitherto concealed from Parliament and the public.

Imutran's attitude to these unfortunate primates is chilling. In
one fax (see report page
34) discussing the problems importing the baboons into Britain,
an Imutran manager says:

"the broker feels sure the airline will do whatever
we need to get these baboons shifted. Surely we can get the bloody
things from Nairobi to Jo'burg. What say you?"

His boss replies:

"Do it."

In one shipment, the baboons spent 34 hours in cramped transport
crates, a full 10 hours longer than the time approved by the Home
Office. Yet the Home Office, typically, took no action (see report
pages
32-33).

Over four hundred cynomolgus monkeys were bred in captivity in
Mauritius, Indonesia or the Philippines and exported to Britain
to be killed by Imutran. In one shipment, three monkeys were found
dead with blood oozing from their nostrils at Paris airport two
days after leaving the Philippines (see document CY5).
A secret review conducted by Imutran with the Home Office conceded
that the deaths "were probably due to a number of factors":
the crates had breached size and ventilation regulations. The compartments
had been so small that the monkeys had not been able to stand, turn
and lie down in a natural manner. The journey time has also been
far longer than the estimate given by Imutran on their import application
form.

The Government's response? Home Office Minister Mike O'Brien MP
(now a junior foreign minister) misled Parliament in a Written Answer,
stating that the crates had not broken rules on size dimensions
and failing to admit the ventilation breaches (see report section
5.2).

Savage science

Between 1994 and 2000, Imutran's researchers transplanted GM pig
hearts and kidneys into hundreds of monkeys and baboons. (1)
In a bizarre effort to bypass several million years of evolutionary
difference between pigs and primates, Imutran scientists, with backing
from their masters at Novartis Pharma, invented experimental cocktails
of powerful immunosuppressants to try to stop the natural rejection
of the fundamentally 'foreign' organs. The spleens were removed
from many monkeys to further weaken their immune systems. The consequences
were truly horrific (see report chapters
4 and
6).

Having survived captivity and a long, dangerous journey, a quarter
of the primates died from 'technical failures' - jargon for lethal
shortcomings in the experimental surgery:

Hearts from piglets would not fit into the necks of baboons
(see document ND10.2),
despite assurances to the contrary (see documents ND6.8
& 6.9).

A pig kidney was accidentally frozen while waiting to be transplanted
into the abdomen of monkey A166M - the transplant went ahead anyway
and the primate died shortly afterwards (see document HLSAPP7B.2
and study IAN020
clinical signs page 135).

Another monkey died when a swab was left in his abdomen following
surgery, leading to a lethal infection of the spleen (see documents
CY22.2,
HLSAPP7A.3,
HLSAPP7B.2).

A series of experimental surgeries performed by out-of-practice
surgeons went fatally wrong (see document CY18.1).
Lethal blood clotting and bleeding complications occurred on a
regular basis throughout the whole period of research.

A few pig organs were rejected almost instantaneously, undermining
the only difference between Imutran's GM pigs and normal pigs
(see document WCB29.1
and report page
57).

Sometimes the hearts or kidneys would simply not function after
transplantation (see document CY18.1).

If the monkeys and baboons survived surgery, they then faced an
inevitable, traumatic death from one or a combination of these factors:
organ rejection and failure, infections resulting from severely
impaired immune systems, and/or drug toxicity. For example, kidney
failure results in an accumulation of waste products such as urea
in the blood. This in turn leads to nausea, vomiting, lethargy,
listlessness, swelling, huddling in pain, drowsiness, anorexia and
eventually death.

Science or alchemy?

Way back in 1995, Imutran scientists told a news conference that
they were ready to start transplanting pig hearts into humans within
a year. This was based on the apparent success of their GM organs
in avoiding the immediate, destructive hyper-acute rejection caused
by such drastic cross-species transplants. Despite other scientists
warning that there would be further, huge obstacles to pig organ
transplants, Imutran scientists raised false hopes in transplant
patients. In 1996, the Swiss multinational drug company Sandoz (now
Novartis Pharma following a merger with Ciba) bought Imutran in
the hope of cashing in on the biotech company's apparent success.
The market for pig organ transplants was predicted to be worth $6
billion annually. How much Imutran's founder scientists made from
the sale of their company remains a mystery.

But, published scientific papers from Imutran have failed to reveal
the full truth of their research (see report page
53). Animals were claimed to be healthier than they really were
(see report pages
56-58). Failures are very rarely reported publicly. Imutran
promotional literature has played down the colossal barriers to
transplanting pig organs into humans. Yet more predictions of imminent
human trials have been made. Behind the scenes and with concern
mounting regarding the dangers of virus transfer and lack of progress
in extending survival times, in April 2000 Imutran were given just
18 months to engineer a quantum leap in survival periods to be able
to commence tests on humans (see report page
17). However, Novartis abruptly closed
Imutran down just six months later - five days after the news
of Diaries of Despair broke.

Significantly, Imutran's experiments in the UK stopped in early
2000 and their research moved to countries in Europe and North America
with virtually no controls on vivisection, not even on paper. Why
did this happen? We know that Novartis actively considered proposals
to move research on baboons to South Africa because of the absence
of legal protection for animals (see document WCB19.2).
Were their experiments on primates deemed too cruel and pointless
even for their supporters in the British Government?

Expert advisors to the UK Government have since referred to Imutran's
research programme as leading up a 'blind alley' and have expressed
deep scepticism about the prospects for viable pig organ transplants.
(2) In five years of experiments,
causing severe suffering to hundreds of primates and sacrificing
thousands of pigs, Imutran and Novartis managed to squeeze average
survival times up by a couple of weeks. Very little progress was
made in overcoming the profound immunological obstacles to xenotransplantation.
Is the notion of functioning pig organ transplants nothing more
than scientific arrogance driven by personal ambition and commercial
greed? Transforming organs from pigs into human organs appears to
be nothing more than a modern form of alchemy.

A further, constant source of concern about xenotransplantation
centres on the potential for new viruses or other diseases to be
introduced into the human population via pig organs or cells. Types
of retroviruses - cousins of the HIV virus - that cannot be removed
from pigs have been shown to have the potential to infect and multiply
in human cells. The spectre of creating another AIDS-style pandemic
hangs over the whole technology of cross-species transplants. (3)

The contrast between the public relations image of Imutran's experiments
and the harsh reality has a number of serious consequences. Firstly,
it distorts democratic public debate about the ethical acceptability
of xenotransplantation research. Then, the potential of undermining
the effectiveness of the human organ donor register - resulting
in less organ transplants and therefore human suffering - has been
noted by an expert advisory committee. (4)
It also signifies the ruthlessness of multinational companies in
pursuing their business strategies regardless of considerations
of compassion, fairness and democracy. Finally, it exposes the rotten
core at the heart of the UK Government's regulation of animal experiments.

Government treachery

The Diaries of Despair reveals direct collusion between Imutran,
Novartis and the Government, and systematic bias in policy on animal
experiments. It provides irrefutable evidence of an unscrupulous
regime and confirms a pattern that has emerged from several exposés
of vivisection in Britain. Corporate lobbying has led to a contemptuous
disregard for animal welfare and the rule of law on the part of
the Government.

One of the key aspects of the UK regulatory system involves the
banding of experiments according to their severity. One document
exposes how the Government's Home Office deliberately and blatantly
colluded with Imutran and its parent company (then known as 'Sandoz')
to underestimate the suffering caused by many of Imutran's experiments
(see document CY14.1).
This would make it easier for the proposed experiment to receive
a licence. Government inspectors show a lack of respect for the
very regulatory system they are charged with enforcing, referring
to an expert committee meeting to discuss an Imutran application
as merely a 'rubber-stamping' exercise (see document CY24.2).
Mistakes and breaches by Imutran and Huntingdon Life Sciences have
been covered up by the Government - the documents reveal the deceit
in stark terms (see report sections
7.5 and 7.8).

The central feature of the British law governing animal experiments
is the cost-benefit assessment. By law, the Home Secretary must
weigh up the costs of the experiments in terms of animal suffering,
against the likelihood of potential benefits resulting from the
experiments. (5) In reality,
the Government places no effective weight on the most fundamental
interests of animals, while failing to question the unrealistic
and heavily-spun claims of public health benefits put forward by
researchers. The demands of the powerful and the influential hold
more sway than the scientific reality, the wishes of Parliament,
public opinion or the welfare of animals.

Uncaged Campaigns submitted the full dossier to the Government
and asked for the establishment of an independent judicial inquiry
into the scandal - this would be the only constitutionally appropriate
method of investigation. Instead, the Home Office set up an internal
review, carried out by the very body whose desperate failures were
exposed by the Diaries of Despair - the Home Office Inspectorate.
Furthermore, the internal review only dealt with a small proportion
of the issued raised in Diaries of Despair. Even the toothless watchdog,
the Animal Procedures Committee (APC),
was stirred to criticism. The subsequent report of the Chief Inspector
exploited the information vacuum created by the injunction, sweeping
the scandal under the carpet with a mixture of inaccuracy and evasion.
(See the Government section.)

The second leak of documents from the
Home Office has allowed us to delve even deeper into the murky world
of vivisection and the Government's support for the practice. The
correspondence between Imutran and the Home Office, together with
applications for experimental licences reveal glaring falsehoods
in the Government's main political defence to this crisis, the Chief
Inspector's review. Imutran's estimations of suffering and success
are disclosed as economical with the truth. There are fascinating
glimpses into a research programme out of control. While the Government
was prepared to privately chastise Imutran (see documents ND13,
ND15
and ND17)
when push comes to shove they lacked the political will and the
integrity to uphold the rule of law in the face of undue pressure
from business interests.

By trying to cover-up their failings, the Government has gambled
that their shameful behaviour would remain hidden. They have lost.

Public interest wins out

Five days after the original disclosure of the Diaries of Despair
on 21 September 2000, Imutran Ltd obtained a temporary injunction
from the High Court in London banning the publication of the report
and the entire haul of leaked documents. Imutran had claimed that
the Defendants, Uncaged Campaigns Ltd and Dan Lyons (director of
Uncaged Campaigns and author of the Diaries of Despair report) had:

wrongfully used and disclosed confidential information; and

infringed the copyright in those documents which they claimed
were copyright documents

Imutran and Novartis Pharma (who joined the action in April 2001)
were seeking a permanent injunction preventing publication of the
documents, together with costs and damages. We estimate their total
costs to have been in the region of £500,000.

From the very beginning, we had defended our right to freedom of
expression on the grounds that there was an overwhelming
public interest in the publication of the Imutran documents
because they revealed a number of extremely serious ethical and
political concerns and failures:

invasive and painful experiments on higher primates

the risk of dangerous viruses being spread to humans by Imutran/Novartis'
experiments

the Home Office's collusive relationship with Imutran and its
failure to monitor and apply regulations properly

inaccurate claims made by Imutran/Novartis concerning the success
of their research and the welfare of the primates they have destroyed

the infliction of "severe" suffering on animals which
is supposedly banned by British and EU legislation

The issue of the independence and integrity of the UK Government's
Home Office was particularly crucial to the Defence. Imutran and
Novartis argued that disclosure of the leaked documents to the Home
Office was sufficient to meet any public interest concerns arising
from their documents. However, given that the documents provided
strong evidence of deliberate malpractice and bias on the part of
the Home Office, we believed that such disclosure was inadequate
in a democratic society.

We have now won the right to publish the majority of the documents
that we had listed as directly supporting the five key elements
of the public interest defence. In addition, the Diaries of Despair
report is now published in virtually complete form, and it contains
additional significant information extracted from documents that
remain injuncted.

The outcome of the legal battle is an overwhelming
endorsement for our campaign for an independent judicial inquiry
into this horrific scandal.

FOOTNOTES

Leaked documents from the Home Office reveal for
the first time how Imutran also grafted monkey hearts into baboons,
hoping to develop primate organs to market for transplantation
into seriously ill infants. This scheme appears to have been knocked
on the head when other scientists pointed out that transplanting
primate organs into humans was a dangerous biohazard and unethical,
both in terms of the proposed large-scale destruction of primates
as well as the concept of using babies as the first human guinea
pigs.

In a report to the Home Office (see document CY18),
an Imutran researcher tells an Inspector that an anaesthetic drug
was prescribed at 'very high doses' to two monkeys, leading to their
deaths.

The clinical signs [for study IAN009] reveal that
one of those primates, Y148f, was found unresponsive and lying on
the cage floor on the morning following transplant - she was then
destroyed. Blood was noted around Y256m's penis and scrotum on his
first day post-transplant. For the next three days he must have
made a pitiful spectacle: slumped against the front of the cage,
drifting in and out of consciousness, his turmoil punctuated by
bouts of vomiting and salivation. He was finally killed on the fourth
afternoon after transplant.

Government response? No punishment for these disastrous
mistakes, then a desperate attempt to exonerate Imutran from blame
while the true facts remained injuncted.

"Members strongly expressed the view that your
response was still not satisfactory and that the failings listed
above indicate a cavalier attitude to the controls of the Act. They
are also extremely concerned that this attitude may extend to the
care and welfare of animals."